MAUDE Adverse Event Report: BECKMAN COULTER STATSPIN SSVT-1 CENTRIFUGE; CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE

Model Number SSVT-1 CENTRIFUGE

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Injury (2348)

Event Date 10/22/2018

Event Type  malfunction  

Manufacturer Narrative

The customer acknowledge they failed to follow instructions to use the plastic inner shield during spin cycles as required.Customer technical support (cts) provided customer with most recent statspin safety notice, safety shield and a trained customer with importance of installing shield.The customer confirmed there was no damage to lid, hinge or latch of centrifuge.Cts initiated return merchandise authorization (rma) process to return centrifuge for repair.The customer was provided with a replacement centrifuge to resolve the issue.Beckman coulter internal identifier is case- (b)(4).

Event Description

The customer reported statspin ssvt-1 centrifuge rotor broke during use and broken rotor pieces hit a lab associate in the leg.There was no adverse event reported.The associate did not seek medical attention for the incident.

• Brand Name: STATSPIN SSVT-1 CENTRIFUGE
• Type of Device: CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821 8000
• Manufacturer (Section G): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821 8000
• Manufacturer Contact: david davis ; 250 s. kraemer blvd.; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 8113289
• MDR Text Key: 128924967
• Report Number: 2050012-2018-01039
• Device Sequence Number: 1
• Product Code: JQC
• UDI-Device Identifier: 10873037000278
• UDI-Public: (01)10873037000278(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SSVT-1 CENTRIFUGE
• Device Catalogue Number: X00-003917-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/16/2018
• Date Manufacturer Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: FA-24395
• Patient Sequence Number: 1
• Patient Outcome(s): Other